An interventional study of AI-Assisted Colonoscopy in Colorectal Neoplasms, Colonic Polyp and Adenoma, sponsored by Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 40 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Zhejiang University · Not applicable, Interventional, and Screening
This study is a multi-center, randomized controlled trial designed to evaluate whether an artificial intelligence (AI) system can assist endoscopists to improve the detection rate of colorectal adenomas and cancers during colonoscopy compared to standard colonoscopy. Early screening and diagnosis are key to reducing the burden of colorectal cancer, but current colonoscopy has limitations, including the risk of missed lesions. This trial aims to determine if AI can enhance screening quality and diagnostic accuracy.
Colorectal cancer (CRC) screening is crucial for early detection and reducing mortality, yet current colonoscopy techniques face challenges such as variable adenoma detection rates (ADR) and the risk of missed diagnoses for subtle lesions. This study is a prospective, multi-center, parallel-group, randomized controlled trial aiming to validate the clinical value of an AI-assisted diagnostic system in improving screening quality. A total of 3300 participants will be randomized in a 1:1 ratio to undergo either AI-assisted colonoscopy (Experimental Group) or conventional high-definition colonoscopy (Control Group). The primary objective is to compare the ADR between the two groups. Secondary objectives include assessing the detection rate of advanced or specific types of polyps, the mean number of adenomas per procedure, and the impact of the AI system on both patient and physician satisfaction. The study will provide high-quality evidence for the standardized application of AI technology in CRC screening, with the ultimate goal of reducing the incidence and mortality of colorectal cancer.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 3,300 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Zhejiang University is the lead sponsor of 356 studies on the registry; 166 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Withdrawal Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo a high-definition colonoscopy procedure where a real-time artificial intelligence system analyzes the video feed to assist the endoscopist in identifying and highlighting suspicious lesions.
Device: AI-Assisted Colonoscopy
Participants will undergo a standard high-definition colonoscopy procedure performed by a qualified endoscopist without the assistance of the artificial intelligence system. The AI software will not be active during these procedures.
High-definition colonoscopy procedure with a real-time video analyzed artificial intelligence system.
Adenoma Detection Rate (ADR)
The proportion of participants with at least one histologically confirmed colorectal adenoma or adenocarcinoma. Detection and specimen collection occur during the colonoscopy, with final confirmation based on pathology reports.
Time frame: From the day of the procedure up to 14 days post-procedure.
Mean Adenomas Per Colonoscopy (APC)
The mean number of histologically confirmed adenomas detected per participant. The number of polyps is counted during the procedure, but confirmation of adenoma status depends on pathology.
Time frame: From the day of the procedure up to 14 days post-procedure.
Advanced adenoma detection rate
The proportion of participants with at least one histologically confirmed advanced adenoma, defined as an adenoma at least 10 mm in diameter, or with high-grade dysplasia, or with a villous component.
Time frame: From the day of the procedure up to 14 days post-procedure.
Serrated lesion detection rate
The proportion of participants with at least one histologically confirmed flat serrated lesion, including sessile serrated lesions with or without dysplasia and traditional serrated adenomas. Hyperplastic polyps are reported separately.
Time frame: From the day of the colonoscopy up to 14 days after the procedure.
Patient Satisfaction Score
Assessed using a 5-point Likert scale questionnaire evaluating examination comfort and acceptance of the AI system (1=very unsatisfied, 5=very satisfied).
Time frame: Assessed within 1 hour after completion of the colonoscopy procedure.
Proximal adenoma detection rate
The proportion of participants with at least one histologically confirmed adenoma located proximal to the splenic flexure.
Time frame: From the day of the colonoscopy up to 14 days after the procedure.
Physician Satisfaction Score
Assessed using a 5-point Likert scale questionnaire evaluating the AI system's usability and reliability (1=very unsatisfied, 5=very satisfied).
Time frame: Assessed within 1 hour after completion of the colonoscopy procedure.
Incidence of Procedure-Related Adverse Events
The number and type of adverse events (AEs) and serious adverse events (SAEs), including but not limited to perforation, significant bleeding, and infection, are recorded.
Time frame: From the start of the procedure up to 30 days post-procedure.
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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